Change Control SOP

Quick Overview

This Standard Operating Procedure (SOP) for a well structured Change Control Process is ready to use and meets authorities’ expectations. The 10-page SOP includes a 2 pages template and only needs some minor modification before it can be followed by your personnel and guarantees an effective Change Control system.

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Details

General

Without a robust and effective change control system you will not be able to adjust systems and processes assuring compliance and staying competitive within the industry. Managing changes probably guarantees your company’s future success.

Scope:

The purpose of this SOP is to describe in detail the change control process. The Process starts with a request for a change followed by the mandatory assessments and approvals. This standard process ensures that all planned changes related to all aspect of manufacture, testing and distribution are reviewed, assessed and approved by technical and quality competent personnel. One of the main tasks is to evaluate all potential impacts followed by correlative consequences of the requested change on product quality, current Good Manufacturing Practice (cGMP), including qualification and validation and the regulatory file/dossier before approval and implementation of a change control request.

Objective:

This procedure applies to all new and existing manufacturing/packaging processes, utilities, major equipment, computerized systems, facilities, drug products and drug substances, raw materials, components, testing requirements, specifications and systems for marketed products and clinical trials (clinical, pre-clinical and stability with GMP implications). Documents and systems that may be impacted by a given change in any of these areas include, but are not limited to, all master documents, Marketing Authorization Applications (MAA’s), New Drug Applications (NDA’s), validation, stability protocols and control systems